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Coronary Hybrid Revascularisation Study

Primary Purpose

Significant Coronary Artery Disease

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Combined CABG and PCI
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Significant Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable, unstable angina pectoris and ACS.
  • Significant stenosis of LAD, segment 1 or 2 and of other coronary arteries.
  • The patient can be treated with a mammary graft to LAD and by balloon or stent of other lesions.
  • Signed informed consent must be available.

Exclusion Criteria:

  • Earlier cardiac surgery
  • Treatment with coronary stent within one year.
  • ST-elevation infarction within 24 hours.
  • Coronary artery lesions located to LAD, segment 1 or 2, which cannot be treated by coronary bypass operation.
  • Stenosis of diagonal branches, CX artery and the right coronary artery, which cannot be treated by PCI.
  • Expected survival <1 year following successful treatment.
  • Allergy to aspirin, clopidogrel, ticlopidine and/or prasugrel.
  • Allergy to sirolimus, everolimus, zotarolimus og biolimus

For the patients treated with coronary hybrid intervention in the same seance further exclusion criteria:

Known disorder of the bloods ability to coagulate (such as renal failure (dialysis or renal creatinine clearance < 50ml/min), congenital coagulopathy, needs for anticoagulant treatment before surgery) Previous gastrointestinal bleeding or previous cerebral

Sites / Locations

  • Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Result of combined CABG and PCI treatment

Arm Description

The registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters.

Outcomes

Primary Outcome Measures

Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE

Secondary Outcome Measures

Combined endpoint of death, stroke, MI and new revascularisation.
Individual endpoints of death, stroke, MI and new revascularisation.
Death
Procedure related biomarker release
Reoperation for bleeding
Operation for suspected sternal infection
CT verified pulmonary embolism
CCS angina class
NYHA function class
Duration of hospitalisation related to the index treatment
Duration of admission for the index treatment
Angiographic endpoints
Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.

Full Information

First Posted
December 19, 2011
Last Updated
February 16, 2022
Sponsor
Aarhus University Hospital Skejby
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1. Study Identification

Unique Protocol Identification Number
NCT01496664
Brief Title
Coronary Hybrid Revascularisation Study
Official Title
Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2010 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters. Based on existing literature we expect the results of coronary artery bypass grafting of the anterior descendent coronary artery (LAD), segment 1 and 2, using the so-called mammary artery graft, to be superior to stent treatment of the same artery. At the same time a catheter based intervention using balloon, bare metal stents (BMS) or drug eluting stents (DES) seems to be a better treatment that a saphenous vein graft for other coronary arteries than the LAD. I.e. the right coronary artery (RCA) and the left circumflex coronary artery (CX). Therefore, we expect a combination of the mentioned surgical and catheter based techniques to be a better treatment than bypass operation or catheter based intervention alone.
Detailed Description
A total of 150 consecutive patients will be included in the study. The patients will have a coronary artery narrowing located to the LAD, which can be treated with a mammary graft, and a stenosis located to other coronary arteries (RCA and CX), which can be treated by balloon or stent. The patients included in the study will be recruited from patients who are referred to the Department of Cardiology/Department of Thoracic Surgery, Aarhus University Hospital, Skejby for treatment of significant coronary artery disease. We will not announce for patients, and the patients will not receive a honorarium for participation. The first 100 patients will be treated i two seances; operation and stent treatment with few days interval. The last 50 patients will be treated in a hybrid operation room with operation and stent treatment in the same seance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Significant Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Result of combined CABG and PCI treatment
Arm Type
Experimental
Arm Description
The registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters.
Intervention Type
Procedure
Intervention Name(s)
Combined CABG and PCI
Intervention Description
Coronary artery bypass grafting Percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE
Time Frame
After 1 year
Secondary Outcome Measure Information:
Title
Combined endpoint of death, stroke, MI and new revascularisation.
Time Frame
After 1 month and after 1, 3 and 5 years
Title
Individual endpoints of death, stroke, MI and new revascularisation.
Time Frame
After 1 month and after 1, 3 and 5 years
Title
Death
Time Frame
Baseline, 1 month, 1, 2, 3, 4 and 10 years
Title
Procedure related biomarker release
Time Frame
Baseline, 1, 3 and 5 year
Title
Reoperation for bleeding
Time Frame
Baseline, 1, 3 and 5 year
Title
Operation for suspected sternal infection
Time Frame
Baseline, 1, 3 and 5 year
Title
CT verified pulmonary embolism
Time Frame
Baseline, 1, 3 and 5 year
Title
CCS angina class
Time Frame
1, 3 and 5 year
Title
NYHA function class
Time Frame
1, 3 and 5 year
Title
Duration of hospitalisation related to the index treatment
Time Frame
Baseline
Title
Duration of admission for the index treatment
Time Frame
Baseline
Title
Angiographic endpoints
Description
Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable, unstable angina pectoris and ACS. Significant stenosis of LAD, segment 1 or 2 and of other coronary arteries. The patient can be treated with a mammary graft to LAD and by balloon or stent of other lesions. Signed informed consent must be available. Exclusion Criteria: Earlier cardiac surgery Treatment with coronary stent within one year. ST-elevation infarction within 24 hours. Coronary artery lesions located to LAD, segment 1 or 2, which cannot be treated by coronary bypass operation. Stenosis of diagonal branches, CX artery and the right coronary artery, which cannot be treated by PCI. Expected survival <1 year following successful treatment. Allergy to aspirin, clopidogrel, ticlopidine and/or prasugrel. Allergy to sirolimus, everolimus, zotarolimus og biolimus For the patients treated with coronary hybrid intervention in the same seance further exclusion criteria: Known disorder of the bloods ability to coagulate (such as renal failure (dialysis or renal creatinine clearance < 50ml/min), congenital coagulopathy, needs for anticoagulant treatment before surgery) Previous gastrointestinal bleeding or previous cerebral
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30903175
Citation
Rimestad JM, Christiansen EH, Modrau IS. One-year cost-effectiveness and safety of simultaneous hybrid coronary revascularization versus conventional coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):217-223. doi: 10.1093/icvts/ivz083. Epub 2019 Mar 21.
Results Reference
derived
PubMed Identifier
26432721
Citation
Modrau IS, Holm NR, Maeng M, Botker HE, Christiansen EH, Kristensen SD, Lassen JF, Thuesen L, Nielsen PH; Hybrid Coronary Revascularization Study Group. One-year clinical and angiographic results of hybrid coronary revascularization. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1181-6. doi: 10.1016/j.jtcvs.2015.08.072. Epub 2015 Aug 28.
Results Reference
derived
PubMed Identifier
24103704
Citation
Modrau IS, Nielsen PH, Botker HE, Christiansen EH, Krusell LR, Kaltoft AK, Maeng M, Terkelsen CJ, Kristensen SD, Lassen JF, Thuesen L. Feasibility and early safety of hybrid coronary revascularisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention. EuroIntervention. 2015 Feb;10(10):e1-6. doi: 10.4244/EIJV10I10A195.
Results Reference
derived
Links:
URL
https://eurointervention.pcronline.com/article/feasibility-and-early-safety-of-hybrid-coronary-revascularisation-combining-off-pump-coronary-surgery-through-j-hemisternotomy-with-percutaneous-coronary-intervention
Description
Feasibility and early safety of hybrid coronary revasculatisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention
URL
https://www.ncbi.nlm.nih.gov/pubmed/26432721
Description
One year clinical and angiographic results of hybrid coronary revascularisation
URL
https://academic.oup.com/icvts/article/29/2/217/5418810
Description
Related Info
URL
https://www.jtcvs.org/article/S0022-5223(15)01535-4/fulltext
Description
Related Info
URL
https://eurointervention.pcronline.com/article/feasibility-and-early-safety-of-hybrid-coronary-revascularisation-combining-off-pump-coronary-surgery-through-j-hemisternotomy-with-percutaneous-coronary-intervention
Description
Related Info

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Coronary Hybrid Revascularisation Study

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